Outlet Pathway Connectors for Catheter Assemblies

Abstract

The catheter assembly (100) includes an outer shaft (112), the outer shaft (112) having an outer shaft body (130) forming an outer shaft hole (136), the outer shaft hole (136) accommodating the inner shaft (110). The outer shaft has a line transition portion (140). The catheter assembly includes an outlet path connector (200), which is connected to the outer shaft body at the line transition portion. The outlet path connector has a rigid body portion (210) separated from and independent of the outer shaft body, and the rigid body portion (210) is connected to the outer shaft body. The body portion defines an outlet path connector hole (216) accommodating the inner shaft. The body portion has a side outlet port (220) at a side (222) of the body portion, and the side outlet port is open toward the outlet path connector hole. The catheter assembly includes a catheter line (114), and the catheter line (114) passes from the inside of the cable outlet port through the side outlet port to the outside of the cable outlet port.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 900,208, filed on September 13, 2019, entitled “Outlet Path Connector for a Catheter Assembly,” U.S. Provisional Patent Application No. 62 / 905,860, filed on September 25, 2019, entitled “Outlet Path Connector for a Catheter Assembly,” and U.S. Patent Application No. 17 / 008,849, filed on September 1, 2020, entitled “Outlet Path Connector for a Catheter Assembly,” all of which are incorporated herein by reference in their entirety. Technical Field

[0003] The subject matter herein relates generally to catheter assemblies. Background Art

[0004] Catheter assemblies are used to monitor patients or perform medical procedures on patients during medical procedures. Some known catheter assemblies include a line extending the length of the catheter, such as for monitoring the patient at the distal end of the catheter or for actuating the distal end of the catheter to manipulate the catheter into place. The catheter line is usually guided through the interior of the catheter assembly. However, the catheter line is led out through the side of the catheter body to be connected to an actuator or monitoring device. The line outlet opening is usually formed by cutting or cutting the outer shaft of the catheter to form a line outlet. Such a line outlet opening can cause weak areas or potential failure areas. In addition, the line outlet opening is usually formed in multiple processing steps. Due to the flow of materials during the forming process, it may be difficult to control the formation of an appropriate line outlet angle and line outlet position. The line outlet forming process is usually performed manually, resulting in inconsistent forming.

[0005] There remains a need for a reliable and cost-effective catheter assembly having a wire exit port for routing a wire within the catheter assembly. Summary of the invention

[0006] In one embodiment, a catheter assembly is provided, which includes an inner shaft extending between a proximal end and a distal end and an outer shaft extending between the proximal end and the distal end. The outer shaft includes an outer shaft body forming an outer shaft hole for accommodating the inner shaft. The outer shaft has a wire transition section near its proximal end. The catheter assembly includes an outlet path connector, which is connected to the outer shaft body at the wire transition section. The outlet path connector has a rigid body part separated from the outer shaft body and independent of the outer shaft body, and the rigid body part is connected to the outer shaft body. The rigid body part defines an outlet path connector hole for accommodating the inner shaft. The rigid body part has a side outlet port at the side of the rigid body part, and the side outlet port is open toward the outlet path connector hole. The catheter assembly includes a catheter wire extending between the distal end and the proximal end of the outer shaft. The catheter wire passes through the side outlet port from the inside of the cable outlet connector to the outside of the cable outlet port. The catheter wire extends from the outlet path connector to the distal end of the outer shaft in the outer shaft hole.

[0007] Optionally, the rigid body portion of the outlet pathway connector may be made of a different material than the outer shaft body.The outer shaft may be discontinuous at a line transition portion, the line transition portion comprising a front section and a rear section, the outlet pathway connector being located between and connecting the front section and the rear section.

[0008] Alternatively, the outer shaft may include an inner layer defining an outer shaft aperture. The outlet pathway connector may be connected to the inner layer at the seam. The outer shaft may include an outer layer in a suitable position around the inner layer and the outlet pathway connector at the seam.

[0009] Optionally, the outlet path connector may include a forwardly extending front engagement portion of the rigid body portion. The front engagement portion may be connected to the outer shaft body. The front engagement portion may include a lap joint connected to the outer shaft. The outer shaft may include an inner layer defining the outer shaft hole and an outer layer surrounding the outside of the inner layer. The front engagement portion may be connected to the inner layer at a seam. The outer layer may be seamlessly connected to the inner layer and the engagement portion at the seam. The outlet path connector may include a rearwardly extending rear engagement portion of the rigid body portion. The rear engagement portion may be connected to the outer shaft body.

[0010] Optionally, the rigid body portion may include an inner surface and an outer surface. The inner surface may define an outlet pathway connector aperture. The side outlet port may extend between the inner surface and the outer surface at an angle transverse to a bore axis of the outlet pathway connector aperture.

[0011] Optionally, the catheter assembly may include a handle connected to the outer shaft at the proximal end. The handle may have a handle hole that accommodates the proximal end of the outer shaft and the outlet path connector. The catheter line may exit from the side outlet port and enter the handle hole. The outlet path connector may include a handle mounting portion connected to the handle.

[0012] Optionally, the rigid body portion of the outlet pathway connector may be stainless steel.The rigid body portion of the outlet pathway connector may be a 3D printed body portion.

[0013] Optionally, the cable outlet connector may extend between the front and rear.The side outlet port may be located a predetermined distance from the front.The side outlet port may extend at a predetermined angle relative to the bore axis of the outlet pathway connector bore.

[0014] Optionally, the rigid body portion of the cable outlet connector may include a front hub and a rear hub. The front hub may have a larger diameter than the rear hub. A shoulder may be formed between the front hub and the rear hub. The side outlet port passes through the shoulder. The front hub may be thicker than the rear hub.

[0015] Optionally, the outlet pathway connector may include a second side outlet port to accommodate a second catheter wire. The catheter wire may be a pull wire for actuating at least one of the distal end of the inner shaft and the distal end of the outer shaft. The catheter assembly may include a wire lumen to accommodate the catheter wire. The wire lumen may pass through the side outlet port.

[0016] In one embodiment, a catheter assembly is provided, which includes an inner shaft extending between a proximal end and a distal end and an outer shaft extending between the proximal end and the distal end. The outer shaft includes an outer shaft body forming an outer shaft hole for accommodating the inner shaft. The outer shaft has a line transition portion near its proximal end. The catheter assembly includes an outlet path connector, which is connected to the outer shaft body at the line transition portion. The outlet path connector has a front engagement portion, a rear engagement portion, and a main body portion between the front engagement portion and the rear engagement portion. The outlet path connector is separated from the outer shaft body and is independent of the outer shaft body. The front engagement portion is connected to the outer shaft body, and the rear engagement portion is connected to the outer shaft body. The main body has an inner surface and an outer surface. The inner surface defines an outlet path connector hole extending along the hole axis. The outlet path connector hole accommodates the inner shaft. The main body has a side outlet port at the side of the main body. The side outlet port can extend between the inner surface and the outer surface at an angle transverse to the hole axis. The catheter assembly includes a catheter line extending between the distal end and the proximal end of the outer shaft. The catheter line passes through the side outlet port. The catheter wire passes through the front of the side outlet port along the inner surface of the main body portion. The catheter wire passes through the back of the side outlet port along the outer surface of the main body portion. The catheter wire extends from the outlet path connector to the distal end of the outer shaft in the outer shaft hole.

[0017] In another embodiment, an outlet path connector for a catheter assembly is provided, the catheter assembly comprising an inner shaft, an outer shaft and a catheter line extending between the distal end and the proximal end of the catheter assembly. The outlet path connector comprises a front engagement portion, the front engagement portion having a front engagement feature and a front opening between the front engagement features. The front engagement feature is configured to engage the inner layer of the outer shaft, and the front opening is configured to accommodate the polymer material of the outer layer around the inner layer and the front engagement feature. The outlet path connector comprises a rear engagement portion, the rear engagement portion having a rear engagement feature and a rear opening between the rear engagement feature. The rear engagement feature is configured to engage the inner layer of the outer shaft, and the rear opening is configured to accommodate the polymer material of the outer layer around the inner layer and the rear engagement feature. The outlet path connector comprises a main body portion between the front engagement portion and the rear engagement portion. The main body portion has an inner surface and an outer surface. The inner surface defines an outlet path connector hole, which is configured to accommodate the inner shaft. The outlet path connector hole extends along the bore axis. The body portion has a side outlet port at a side of the body portion configured to receive a catheter line. The side outlet port extends between the inner surface and the outer surface at an angle transverse to the bore axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a perspective view of a catheter assembly according to an exemplary embodiment.

[0019] Figure 2 is an exploded view of a catheter assembly according to an exemplary embodiment.

[0020] Figure 3 is a cross-sectional view of a catheter assembly according to an exemplary embodiment.

[0021] Figure 4 is a perspective view of an outlet pathway connector of a catheter assembly according to an exemplary embodiment.

[0022] Figure 5 is a side view of an outlet pathway connector according to an exemplary embodiment.

[0023] Figure 6 is a top view of an outlet pathway connector according to an exemplary embodiment.

[0024] Figure 7 is a front perspective view of an outlet pathway connector according to an exemplary embodiment.

[0025] Figure 8 is a side view of the outer shaft of the catheter assembly in a partially assembled state.

[0026] Fig. 9 is a side view of the outer shaft in the assembled state.

[0027] Fig.10 is a cross-sectional view of a portion of a catheter assembly according to an exemplary embodiment.

[0028] Fig.11 is a cross-sectional view of a portion of a catheter assembly according to an exemplary embodiment.

[0029] Fig.12 is a cross-sectional view of a portion of a catheter assembly according to an exemplary embodiment.

[0030] Fig.13 is a cross-sectional view of a portion of a catheter assembly according to an exemplary embodiment.

[0031] Fig.14 is a perspective view of an outlet pathway connector according to an exemplary embodiment.

[0032] Fig.15 is a perspective view of an outlet pathway connector according to an exemplary embodiment.

[0033] Fig.16 is a front perspective view of an outlet pathway connector according to an exemplary embodiment.

[0034] Fig.17 According to an exemplary embodiment Fig.16 A rear perspective view of the outlet pathway connector shown in FIG.

[0035] Fig.18 is a front perspective view of an outlet pathway connector according to an exemplary embodiment.

[0036] Fig.19 According to an exemplary embodiment Fig.18 A rear perspective view of the outlet pathway connector shown in FIG. DETAILED DESCRIPTION

[0037] Figure 1100 is a perspective view of a catheter assembly 100 according to an exemplary embodiment. The catheter assembly 100 extends between a proximal end 102 and a distal end 104. The catheter assembly 100 includes a handle 106 at its proximal end 102. The handle 106 can be used to actuate or manipulate the distal end 104 and / or one or more medical devices 108 at the distal end 104. For example, the catheter assembly 100 can be a steerable catheter assembly. The handle 106 can rotate and / or translate to actuate or manipulate the distal end 104, such as using a pull line, a spring or other type of actuating element extending between the handle 106 and the distal end 104. In various embodiments, the medical device 108 can be a stent, and the catheter assembly 100 is used to position the stent in the patient's body. In other embodiments, the medical device 108 can be an electrical device such as a sensor at the distal end 104. The electrical device can be electrically connected to the connector via one or more wires (such as an ECG line) extending from the electrical device to the connector. In alternative embodiments, other types of medical devices can be provided.

[0038] Figure 2 1 is an exploded view of a catheter assembly 100 according to an exemplary embodiment. The catheter assembly 100 includes an inner shaft 110, an outer shaft 112, one or more catheter wires 114, and an exit path connector 200 for controlling the position of the catheter wire 114 along the outer shaft 112. In various embodiments, the catheter wire 114 can have a spring coil or sheath extending the length of the catheter wire 114 to protect the catheter wire 114. The inner shaft 110 is configured to be coaxially disposed within the outer shaft 112. The exit path connector 200 is used to guide the catheter wire 114 from the interior of the outer shaft 112 to the exterior of the outer shaft 112. The exit path connector 200 provides a side exit point for the catheter wire 114.

[0039] The handle 106 is configured to be connected to the outer shaft 112 and the outlet path connector 200 at the proximal end 102. In an exemplary embodiment, the handle 106 includes a handle hole 116 that receives the outer shaft 112 and the outlet path connector 200. The handle 106 can be connected to the inner shaft 110 to move the inner shaft 110 relative to the outer shaft 112. In various embodiments, the handle 106 includes one or more actuators 118, such as a lever, to move the inner shaft 110 relative to the outer shaft 112. In various embodiments, the handle 106 is operably connected to the catheter line 114. For example, the catheter line 114 can be a pull wire, spring, or other type of actuator connected to the inner shaft 110 and / or the outer shaft 112 at the distal end 104 for actuating the distal end 104 of the catheter assembly 100. In alternative embodiments, other types of wires can be provided, such as an electric wire for transmitting a data signal from the medical device 108 to the proximal end 102 of the catheter assembly 100. The catheter line 114 can be a probe cable in various other embodiments.

[0040] The inner shaft 110 includes an inner shaft body 120 extending between a proximal end 122 and a distal end 124. In other embodiments, the medical device 108 can be held by the inner shaft 110 at the distal end 124. In one embodiment, the inner shaft body 120 is a hollow tubular member. In various embodiments, the inner shaft body 120 includes an inner layer 126 and an outer layer 128 surrounding the inner layer 126. The inner shaft body 120 can include multiple layers, such as multiple inner layers or multiple outer layers, as a stack of materials. The multiple layers of the inner shaft body 120 provide structural support, coverings, lubricating surfaces, etc. The inner shaft body 120 can be flexible, such as for manipulating the inner shaft 110 in a patient's body. For example, the inner layer 126 can be spirally cut, or include multiple grooves cut in its wall to increase the flexibility of the inner layer 126. In various other embodiments, the inner layer 126 can be a braided inner layer, such as a stainless steel wire mesh braid. Alternatively, the inner layer 126 can be a hypodermic tube or a hypotube. However, in alternative embodiments, the inner layer 126 can be another type of structure. In various embodiments, the inner layer 126 is a structural layer that provides structural support and provides the approximate shape of the inner shaft body 120, while the other layers including the outer layer 128 are supported by the inner layer 126. In various embodiments, the inner layer 126 can be a solid rod rather than a tubular structure. An inner coating can be applied to the inner surface of the inner layer 126, for example to form a lubricated surface. For example, the inner coating can be a PTFE liner, a FEP liner, or other various medical grade thermoplastic elastomer coatings.

[0041] In an exemplary embodiment, the outer layer 128 is made of a polymer material having low friction properties, such as a fluoropolymer material, a mixture of fluoropolymer materials, a nylon material, a polyethylene material, etc. The outer layer 128 can be made of a material having good flexural properties. In various embodiments, the outer layer 128 is a polymer sheath. In various embodiments, a polymer layer can be provided along both the inner surface and the outer surface of the inner shaft 110. Optionally, the inner layer 126 can be used as a forming structure for forming the outer layer 128, and the inner layer 126 can be removed after the outer layer 128 is formed so that the inner shaft 110 includes only the outer layer 128. In various embodiments, the outer layer 128 can be spirally cut or include a plurality of grooves cut on its wall to increase the flexibility of the inner shaft 110.

[0042] The outer shaft 112 includes an outer shaft body 130 extending between a proximal end 132 and a distal end 134. The outer shaft body 130 forms an outer shaft bore 136 that receives the inner shaft 110. The inner shaft 110 can move relative to the outer shaft 112 within the outer shaft bore 136. For example, the inner shaft 110 can move axially relative to the outer shaft 112 and / or the inner shaft 110 can rotate relative to the outer shaft 112. In one embodiment, the catheter line 114 is guided within the outer shaft bore 136 between the distal end 134 and the outlet path connector 200, such as in the space between the outer shaft body 130 and the inner shaft body 120. The outlet path connector 200 transitions the catheter line 114 between the interior of the outer shaft 112 and the exterior of the outer shaft 112 through a side outlet port, such as for connection to the handle 106 or other device.

[0043] In various embodiments, the outer shaft body 130 includes an inner layer 146 and an outer layer 148 surrounding the outside of the inner layer 146. The outer shaft body 130 may include multiple layers, such as multiple inner layers or multiple outer layers, as a stack of materials. The multiple layers of the outer shaft body 130 provide structural support, coverings, lubricated surfaces, etc. The outer shaft body 130 can be flexible, for example, for manipulating the outer shaft 112 in the patient's body. For example, the inner layer 146 can be spirally cut, or include multiple grooves cut on its wall to increase the flexibility of the inner layer 146. In other various embodiments, the inner layer 146 can be a braided inner layer, such as a stainless steel wire mesh braid. Alternatively, the inner layer 146 can be a hypodermic injection tube or a hypotube. However, in alternative embodiments, the inner layer 146 can be another type of structure. In various embodiments, the inner layer 146 is a structural layer that provides structural support and provides the general shape of the outer shaft body 130, while the other layers including the outer layer 148 are supported by the inner layer 146. In various embodiments, the inner layer 146 can be a solid rod rather than a tubular structure. An inner coating can be applied to the inner surface of the inner layer 146 to form a lubricated surface. For example, the inner coating can be a PTFE liner, a FEP liner, or other various medical grade thermoplastic elastomer coatings.

[0044] In an exemplary embodiment, the outer layer 148 is made of a polymer material having low friction properties, such as a fluoropolymer, a mixture of fluoropolymers, a nylon material, etc. The outer layer 148 can be made of a material having good flexural properties. In various embodiments, the outer layer 148 is a polymer jacket. In various embodiments, a polymer layer can be provided along both the inner surface and the outer surface of the inner layer 146. Optionally, the inner layer 146 can be used as a molding structure for forming the outer layer 148, and the inner layer 146 can be removed after the outer layer 148 is formed so that the outer shaft 112 includes only the outer layer 148. In various embodiments, the outer layer 148 can be spirally cut or include a plurality of grooves cut on its wall to increase the flexibility of the outer shaft 112.

[0045] In an exemplary embodiment, the outer shaft 112 includes a line transition portion 140 adjacent to the proximal end 132 thereof. The outlet pathway connector 200 is connected to the outer shaft body 130 at the line transition portion 140. For example, the outlet pathway connector 200 is connected to the inner layer 146 and / or to the outer layer 148. The outer layer 148 can be formed on a suitable location of the inner layer 146 and / or on a portion of the outlet pathway connector 200 to form a seamless transition across the inner layer 146 and the outlet pathway connector 200. For example, the outer layer 148 can extend over and cover the seam between the inner layer 146 and the outlet pathway connector 200 to increase the stiffness and structural strength at the interface of the outer shaft 112 and the outlet pathway connector 200. In an exemplary embodiment, the outlet pathway connector 200 is separate and independent from the outer shaft body 130, and the outlet pathway connector 200 is connected to the outer shaft body 130 at the line transition portion 140. For example, the outlet path connector 200 is manufactured separately from the outer shaft body 130 (e.g., manufactured separately from the inner layer 146 of the outer shaft body 130, and manufactured separately from the outer layer 148 of the outer shaft body 130). When assembled, the outlet path connector 200 forms a portion of the outer shaft 112 or an extension of the outer shaft 112. For example, the outer shaft body 130 is discontinuous at the line transition portion 140, and the line transition portion 140 includes a front section 142 in front of the line transition portion 140 and a rear section 144 behind the line transition portion 140. The outlet path connector 200 is located between the front section 142 and the rear section 144. The outlet path connector 200 connects the front section 142 and the rear section 144.

[0046] The outlet pathway connector 200 includes a body portion 210 extending between the front section 142 and the rear section. The body portion 210 is hollow and includes an outlet pathway connector aperture 216 ( Figure 413). The outlet path connector hole 216 accommodates the inner shaft 110. When the outlet path connector 200 is connected to the outer shaft body 130, the outlet path connector hole 216 and the outer shaft hole 136 define a continuous hole that accommodates the inner shaft 110. The main body portion 210 includes one or more side outlet ports 220 at the side 222 of the main body portion 210. The outlet path connector 200 defines the outlet path position of the catheter line 114 along the outer shaft 112 by controlling the position of the side outlet ports 220 relative to the front 212 and the rear 214. The outlet path connector 200 controls the outlet path angle of the catheter line 114 from the inside of the outlet path connector 200 to the outside of the outlet path connector 200. For example, the size, shape, position, angle and thickness of the material of the main body portion 210 around the side outlet port 220 are repeatedly and reliably controlled. For example, the main body portion 210 can be manufactured using a precision manufacturing process such as 3D printing, laser cutting, injection molding, machining, etc. In an exemplary embodiment, handle 106 is connected to outer shaft 112 and exit pathway connector 200 to cover the line exit location.

[0047] Figure 3 is a cross-sectional view of a catheter assembly 100 according to an exemplary embodiment. Figure 3 The inner shaft 110 is shown within the outer shaft bore 136 of the outer shaft 112. The catheter wire 114 is guided in the gap 138 between the outer shaft body 130 and the inner shaft body 120. Optionally, the catheter wire 114 can be connected to the inner shaft body 120 and / or the outer shaft body 130 to flex or bend the inner shaft 110 and / or the outer shaft 112 to manipulate the catheter assembly 100 within the patient's body. Figure 3 A handle 106 is shown connected to an outer shaft 112 .

[0048] Figure 4 is a perspective view of an outlet pathway connector 200 according to an exemplary embodiment. Figure 5 is a side view of an outlet pathway connector 200 according to an exemplary embodiment. Figure 6 is a top view of an outlet pathway connector 200 according to an exemplary embodiment. Figure 7 is a front perspective view of an outlet pathway connector 200 according to an exemplary embodiment.

[0049] The outlet path connector 200 includes a main body portion 210 extending between a front portion 212 and a rear portion 214. The front portion 212 is configured to face the distal end of the catheter assembly 100, and the rear portion 214 is configured to face the proximal end 102 of the catheter assembly 100. In an exemplary embodiment, the main body portion 210 is rigid and maintains shape during assembly and use. For example, the main body portion 210 can be made of a metal material such as a stainless steel material. In various other embodiments, the main body portion 210 can be made of a polymer material. Optionally, the polymer material can be a high-temperature polymer material having a higher melting point than the outer layer 148, so that the main body portion 210 maintains shape during the application of the outer layer 148 to the outlet path connector 200. The main body portion 210 can be manufactured by a 3D printing process. In various other embodiments, the main body portion 210 can be manufactured by a machining process. Optionally, the main body portion 210 can be processed after being formed, such as being coated, plated, or subjected to other post-processing. The body portion 210 is rigid to protect the catheter line 114 and prevent damage or breakage at the line exit point. The exit path connector forms a controlled connection joint along the outer shaft 112 for connecting the catheter line 114 to the handle 106 or other device.

[0050] The side outlet ports 220 are arranged along the side 222 of the body portion 210 between the front portion 212 and the rear portion 214. Any number of side outlet ports 220 may be provided. In the illustrated embodiment, the outlet pathway connector 200 includes two side outlet ports 220 arranged at the top; however, in alternative embodiments, more or fewer side outlet ports 220 may be provided, and the side outlet ports 220 may be located at other locations. In various embodiments, the side outlet ports 220 may be approximately centered between the front portion 212 and the rear portion 214. In alternative embodiments, the side outlet ports 220 may be closer to the front portion 212 or closer to the rear portion 214. In some embodiments, the side outlet ports 220 may be located at different axial locations along the side 222 of the body portion 210. The side outlet ports 220 may be at a predetermined distance from the front portion 212 and / or the rear portion 214 at controlled locations of the four exit points of the catheter line 114. The side outlet port 220 extends at an angle transverse to the bore axis 224 of the outlet pathway connector bore 216. The side outlet port 220 extends between an inner surface 226 of the body portion 210 and an outer surface 228 of the body portion 210. The side outlet port 220 defines an opening to allow the catheter line 114 to extend from the interior of the outlet pathway connector 200 to the exterior of the outlet pathway connector 200. The side outlet port 220 has a controlled inlet and outlet for the catheter line 114.

[0051] The body portion 210 includes a front hub 232 at the front portion 212 and a rear hub 234 at the rear portion 214. In an exemplary embodiment, a shoulder 236 is formed between the front hub 232 and the rear hub 234. In one embodiment, the shoulder 236 is formed for attaching the handle 106 (e.g., Figure 2 2 (shown) is connected to a handle mount 238 of the outlet pathway connector 200. For example, the handle mount 238 includes one or more handle locating surfaces for locating the handle 106 relative to the outlet pathway connector 200. For example, the handle 106 can engage a rearwardly facing surface of the shoulder 236 to axially locate the handle 106 relative to the outlet pathway connector 200.

[0052] In an exemplary embodiment, the front hub 232 has a larger outer diameter than the rear hub 234. Optionally, the front hub 232 can have a larger inner diameter than the rear hub 234. Optionally, the body portion 210 can be thicker along the front hub 232 compared to the rear hub 234. However, in other embodiments, the rear hub 234 has a larger diameter than the front hub 232. In various other embodiments, the diameters of the front hub 232 and the rear hub 234 can have the same diameter. Optionally, in such an embodiment, a flange or edge can extend outward from the front hub 232 and / or the rear hub 234 to form a handle mounting portion. In various other embodiments, the front hub 232 and / or the rear hub 234 can have a discontinuous diameter, such as tapering. In an exemplary embodiment, the side outlet port 220 is disposed at the transition between the front hub 232 and the rear hub 234. For example, the side outlet port 220 passes through the shoulder 236. The catheter wire 114 is configured to be guided inside the front hub 232 and outside the rear hub 234. In an exemplary embodiment, the front hub 232 has an increased inner diameter to guide the catheter wire 114 along the interior of the front hub 232, and the rear hub 234 has a reduced outer diameter to guide the catheter wire 114 along the exterior of the rear hub 234. In an exemplary embodiment, the front hub 232 has an increased thickness to provide sufficient material around the side outlet port 220 to reduce breakage of the outlet port connector 200 at the side outlet port 220. In an alternative embodiment, the body portion 210 can be a multi-piece body with a front hub 232 separate from and connected to the rear hub 234.

[0053] In an exemplary embodiment, the outlet pathway connector 200 includes a front engagement portion 240 that extends forwardly of the body portion 210 at the front portion 212. The front engagement portion 240 includes front engagement features 242 and a front opening 244 located between the front engagement features 242. The front opening 244 is located between the front engagement features 242. In the illustrated embodiment, the front opening 244 is open in the front. In various embodiments, the front engagement features 242 can be thinner than the front hub 232 between the inner surface 226 and the outer surface 228. For example, when the outlet pathway connector 200 is connected to the outer shaft 112 ( Figure 2 ), the front engagement feature 242 may be stepped radially inward to provide a space for accommodating the outer layer 148 ( Figure 2 The radial step forms a front shoulder 248 between the front hub 232 and the front connecting portion 240. In the illustrated embodiment, the front engagement feature 242 is a lap joint 246 that is cantilevered from the front portion 212. The lap joint 246 can be a wedge-shaped tab that is thinner at the outer edge of the lap joint 246 and thicker at the base of the lap joint 246 where the lap joint 246 extends from the front hub 232. In various embodiments, the lap joint 246 can be trapezoidal. In alternative embodiments, the front engagement feature 242 and / or the front opening 244 can have other shapes.

[0054] In an exemplary embodiment, the outlet pathway connector 200 includes a rear engagement portion 250 that extends forwardly from the body portion 210 at the rear portion 214. The rear engagement portion 250 includes rear engagement features 252 and a rear opening 254 between the rear engagement features 252. The rear opening 254 is located between the rear engagement features 252. In the illustrated embodiment, the rear opening 254 is open at the rear. In various embodiments, the rear engagement features 252 can be thinner than the rear hub 234 between the inner surface 226 and the outer surface 228. For example, when the outlet pathway connector 200 is connected to the outer shaft 112 ( Figure 2 As shown), the rear engagement feature 252 may be stepped radially inward to provide a space for accommodating the outer layer 148 ( Figure 2 The radial step forms a rear shoulder 258 between the rear hub 234 and the rear connection portion 250. In the illustrated embodiment, the rear engagement feature 252 is a lap joint 256 that is cantilevered from the rear portion 214. The lap joint 256 can be a wedge-shaped tab that is thinner at the outer edge of the lap joint 256 and thicker at the base of the lap joint 256 where the lap joint 256 extends from the rear hub 234. In various embodiments, the lap joint 256 can be trapezoidal. In alternative embodiments, the rear engagement feature 252 and / or the rear opening 254 can have other shapes.

[0055] Figure 8 is a side view of the outer shaft 112 in a partially assembled state. Fig. 9 1 is a side view of the outer shaft 112 in an assembled state. The outlet path connector 200 is located at the line transition portion 140 of the outer shaft 112 between the front section 142 and the rear section 144. However, in alternative embodiments, the outer shaft 112 may not be provided with the rear section 144, and the outlet path connector 200 is located behind the front section 142.

[0056] During assembly, the outlet pathway connector 200 is connected to the inner layer 146 ( Figure 8 ). The front engagement portion 240 is connected to the front section 142 of the inner layer 146, and the rear engagement portion 250 is connected to the rear section 144 of the inner layer 146. In an exemplary embodiment, the inner layer 146 is discontinuous with the main body 210 of the outlet pathway connector 200 between the front section 260 and the rear section 262 of the outer layer 148. The front engagement feature 242 is connected to the inner layer 146 at the front seam 264. For example, the front engagement feature 242 can engage the outer surface of the inner layer 146. A portion of the inner layer 146 extends into the outlet pathway connector hole 216 at the front engagement portion 240. The inner layer 146 is exposed through the front opening 244. The rear engagement feature 252 is connected to the inner layer 146 at the rear seam 266. For example, the rear engagement feature 252 can engage the outer surface of the inner layer 146. A portion of the inner layer 146 extends into the outlet pathway connector hole 216 at the rear engagement portion 250. The inner layer 146 is exposed through the rear opening 254 .

[0057] During assembly, the outer layer 148 ( Fig. 9 ) is connected to the inner layer 146 and the outlet pathway connector 200. For example, the outer layer 148 can be applied in place after the outlet pathway connector 200 is connected to the inner layer 146. In an exemplary embodiment, the outer layer 148 is a heat shrink tubing applied to the outlet pathway connector 200 and the inner layer 146. In other various embodiments, the outer layer 148 is an overmold material that is molded in place over portions of the outlet pathway connector 200 and the inner layer 146. The outer layer 148 can be applied by other processes in alternative embodiments, such as chemical bonding.

[0058] The outer layer 148 surrounds the exterior of the inner layer 146 and surrounds the exterior of the front joining portion 240 and the rear joining portion 250. The outer layer 148 is seamlessly connected to the inner layer 146 and the front joining portion 240 and the rear joining portion 250. For example, the outer layer 148 covers the front seam 264 and the rear seam 266 and forms a seamless transition across the front seam 264 and the rear seam 266. In an exemplary embodiment, the outer layer 148 is discontinuous with the main body 210 of the outlet pathway connector 200 between the front section 270 and the rear section 272 of the outer layer 148. The front section 270 of the outer layer 148 covers the front section 260 and the front joining portion 240 of the inner layer 146. The front section 270 of the outer layer 148 is connected to the front joining feature 242. The front section 270 of the outer layer 148 extends into the front opening 244. The front section 270 of the outer layer 148 joins the front shoulder 248. The rear section 272 of the outer layer 148 covers the rear section 262 and the rear engagement portion 250 of the inner layer 146. The rear section 272 of the outer layer 148 is connected to the rear engagement feature 252. The rear section 272 of the outer layer 148 extends into the rear opening 254. The rear section 272 of the outer layer 148 engages the rear shoulder 258. The outer layer 148 secures the outlet pathway connector 200 to the inner layer 146.

[0059] Fig.10 1 is a cross-sectional view of a portion of the catheter assembly 100 according to an exemplary embodiment, showing a portion of the outlet path connector 200 and the outer shaft 112. The outlet path connector 200 is located between the front section 142 and the rear section 144. The catheter line 114 extends through the outer shaft 112 and the outlet path connector 200 to the side outlet port 220. The outer layer 148 is connected to the outlet path connector 200 at the front joint portion 240 and the rear joint portion 250. The catheter line 114 extends along the front section 142 of the outer shaft 112 through the interior of the outer shaft 112 (e.g., within the outer shaft hole 136), and extends through the interior of the front hub 232 of the outlet path connector 200 (e.g., within the outlet path connector hole 216). The catheter line 114 extends to the outside of the outlet path connector 200 through the side outlet port 220. The catheter line 114 extends along the outside of the rear hub 234 and can extend along the outside of the rear section 144 of the outer shaft 112.

[0060] Fig.11 1 is a cross-sectional view of a portion of a catheter assembly 100 according to an exemplary embodiment. The outlet path connector 200 is located at the line transition portion 140 of the outer shaft 112 between the front section 142 and the rear section 144. The handle 106 is connected to the outer shaft 112 and / or the outlet path connector 200. For example, the handle 106 can engage the outer surface 228 of the body portion 210. The handle 106 can be positioned along the outer shaft 112 and the outlet path connector 200 by engaging with the handle mounting portion 238.

[0061] During assembly, the outlet pathway connector 200 is connected to the inner layer 146 of the outer shaft 112, and the outer layer 148 is connected to the outlet pathway connector 200 and the outer shaft 112. The front engagement portion 240 is connected to the inner layer 146 and the outer layer 148 at the front section 142, and the rear engagement portion 250 is connected to the inner layer 146 and the outer layer 148 at the rear section 144. Optionally, the front engagement feature 242 and the rear engagement feature 252 are located between the inner layer 146 and the outer layer 148. The outer layer 148 is formed around the front engagement feature 242 and the rear engagement feature 252, such as in the front opening 244, the rear opening 254.

[0062] In an exemplary embodiment, the outlet path connector hole 216 and the outer shaft hole 136 are aligned along the hole axis 224. The inner shaft 110 is received in the outer shaft hole 136 and the outlet path connector hole 216. A gap 138 is defined between the inner shaft body 120 and the outer shaft body 130. The gap 138 is also defined between the inner shaft body 120 and the main body portion 210 of the outlet path connector 200. In an exemplary embodiment, the catheter line 114 is guided through the catheter assembly 100 within the gap 138 to the side outlet port 220 of the outlet path connector 200. The catheter line 114 extends through the interior of the outer shaft 112 (e.g., within the outer shaft hole 136) along the front section 142 of the outer shaft 112, and extends through the interior of the front hub 232 of the outlet path connector 200 (e.g., within the outlet path connector hole 216). The catheter line 114 extends through the side outlet port 220 to the outside of the outlet path connector 200. For example, the catheter line 114 extends along the exterior of the rear hub 234 and may extend along the exterior of the rear section 144 of the outer shaft 112. The catheter line 114 may be connected to the handle 106 or other device on the exterior of the outer shaft 112 and / or the exterior of the outlet pathway connector 200.

[0063] Fig.12 2 is a cross-sectional view of a portion of the catheter assembly 100 according to an exemplary embodiment, the cross-sectional view being taken through the front hub 232 of the outlet pathway connector 200 in front of the side outlet port 220. The inner shaft 110 is positioned in the outlet pathway connector aperture 216 with a gap 138 between the inner shaft body 120 and the main body portion 210 of the outlet pathway connector 200. The catheter wire 114 is guided through the catheter assembly 100 within the gap 138.

[0064] Fig.13 2 is a cross-sectional view of a portion of the catheter assembly 100 according to an exemplary embodiment, the cross-sectional view being taken behind the side outlet port 220 through the rear hub 234 of the outlet pathway connector 200. The catheter line 114 extends through the side outlet port 220 to the exterior of the outlet pathway connector 200. The catheter line 114 extends along the exterior of the rear hub 234.

[0065] Fig.14 is a perspective view of an outlet pathway connector 200 according to an exemplary embodiment. The outlet pathway connector 200 includes a main body portion 210 and a side outlet port 220. In the illustrated embodiment, the outlet pathway connector 200 includes a perforated opening 245 at the front engagement portion 240 and a perforated opening 255 at the rear engagement portion 250. In the illustrated embodiment, the perforated openings 245, 255 are circular; however, the perforated openings 245, 255 may have other shapes, such as elliptical, rectangular, arcuate, or other shapes. The perforated openings 245, 255 may be elongated, such as elongated parallel to the axis of the outlet pathway connector 200, perpendicular to the axis of the outlet pathway connector 200, or elongated in other directions. In various embodiments, the front engagement portion 240 includes a hood 247 that accommodates the catheter line 114. Figure 4 Compared to the embodiment shown, in the embodiment shown, the shape of the front joint portion 240 and the rear joint portion 250 are different. The perforated openings 245, 255 are separated by strips 243, 253 at the front joint portion 240 and the rear joint portion 250. The outer layer 148 ( Fig. 9 The strips 243, 253 may cover the strips 243, 253 and fill the perforated openings 245, 255. The strips 243, 253 are configured to be connected to the inner layer 146 ( Figure 8 ).

[0066] Fig.15 2 is a perspective view of an outlet pathway connector 200 according to an exemplary embodiment. The outlet pathway connector 200 includes a body portion 210 and a side outlet port 220. In the illustrated embodiment, the side outlet port 220 is formed by an outlet tube 221 extending from the body portion 210. The outer layer 148 ( Fig. 9 ) is applied to the main body portion 210 to cover the entire main body portion 210, wherein the outlet tube 221 extends through the outer layer 148. The front joint portion 240 and the rear joint portion 250 can be connected to the outer layer 148 and the inner layer 146 ( Figure 8 ).

[0067] Fig.16 is a front perspective view of an outlet pathway connector 200 according to an exemplary embodiment. Fig.17 According to an exemplary embodiment Fig.162 is a rear perspective view of an outlet pathway connector 200 shown in FIG. The outlet pathway connector 200 includes a body portion 210 and a side outlet port 220. The body portion 210 includes a front engagement feature 242 at the front engagement portion 240 and a rear engagement feature 252 at the rear engagement portion 250. The front engagement feature 242, the rear engagement feature 252 include curved distal edges.

[0068] In the illustrated embodiment, the outlet pathway connector 200 includes a perforated opening 280 along a middle portion of the body portion 210, the middle portion being distal to the front engagement portion 240 and distal to the rear engagement portion 250. In the illustrated embodiment, the perforated opening 280 is circular; however, the perforated opening 280 may have other shapes, such as oval, rectangular, arcuate, or other shapes. In alternative embodiments, the perforated opening 280 may be elongated. The perforated openings 280 are separated by bands 282. The outer layer 148 ( Fig. 9 The strip 282 may cover the inner layer 146 (shown in FIG. 1 ) and fill the perforated opening 280. The strip 282 is configured to be connected to the inner layer 146 ( Figure 8 ).

[0069] Fig.18 is a front perspective view of an outlet pathway connector 200 according to an exemplary embodiment. Fig.19 According to an exemplary embodiment Fig.18 . The outlet pathway connector 200 includes a main body portion 210 and a side outlet port 220. The main body portion 210 includes a rear engagement feature 252 at the rear engagement portion 250. The main body portion 210 includes a front perforated opening 245 at the front engagement portion 240. The main body portion also includes a middle perforated opening 280 along the middle portion of the main body portion 210. In the embodiment shown, the perforated opening 280 is an elongated opening, such as an elliptical shape. In alternative embodiments, the perforated opening 280 may have other shapes. In the embodiment shown, the perforated opening 280 is elongated parallel to the axis of the main body portion 210; however, in alternative embodiments, the perforated opening 280 may be perpendicular to the axis or transverse to the axis. The inner layer 146 ( Figure 8 ) may fill the front perforated opening 245 and / or the middle perforated opening 280 .

[0070] It should be understood that the above description is exemplary only, not restrictive. For example, the above embodiments (and / or aspects thereof) can be used in combination with each other. In addition, without departing from the scope of the invention, many modifications can be made to adapt specific situations or materials to the teachings of the present invention. The dimensions, material types, directions of the various components, and the number and position of the various components described herein are intended to define the parameters of certain embodiments, and are by no means restrictive, but are merely exemplary embodiments. After reading the above description, many other embodiments and modifications within the spirit and scope of the claims will be apparent to those skilled in the art. Therefore, the scope of the present invention should be determined with reference to the full scope of the equivalents given by the appended claims and these claims.

Claims

1. A catheter assembly (100), comprising: an inner shaft (110) extending between a proximal end (122) and a distal end (124); an outer shaft (112) having an outer shaft body (130) defining an outer shaft bore (136) receiving the inner shaft, the outer shaft extending between a proximal end (132) and a distal end (134), the outer shaft having a linear transition portion (140) proximate its proximal end; An outlet path connector (200) connected to the outer shaft body at the line transition portion, the outlet path connector having a rigid body portion (210) separated from and independent of the outer shaft body, the rigid body portion (210) having a front engagement portion (240) extending forward, so that the outlet path connector (200) is detachably connected to the outer shaft body through the front engagement portion (240), wherein the front engagement portion (240) includes a lap joint (246) extending from a front cantilever of the rigid body portion (210), the rigid body portion defining an outlet path connector hole (216) for accommodating the inner shaft, the rigid body portion having a side outlet port (220) at a side (222) of the rigid body portion, the side outlet port opening toward the outlet path connector hole; as well as A catheter line (114) extends between the distal end and the proximal end of the outer shaft, the catheter line located between the outer shaft body (130) and the inner shaft body (120) of the inner shaft (110) extending from the inside of the outer shaft (112) through the side outlet port (220) to the outside of the outer shaft (112), and the catheter line extends from the outlet path connector in the outer shaft hole to the distal end of the outer shaft.

2. The catheter assembly (100) according to claim 1, wherein: The rigid body portion (210) of the outlet pathway connector (200) is manufactured from a material different from that of the outer shaft body (130).

3. The catheter assembly (100) according to claim 1, wherein: The outer shaft (112) is discontinuous at the line transition portion (140), the line transition portion including a front section (142) and a rear section (144), the outlet path connector being located between and connecting the front section and the rear section.

4. The catheter assembly (100) according to claim 1, wherein: The outer shaft (112) includes an inner layer (146) defining the outer shaft aperture (136), the outlet pathway connector being connected to the inner layer at a seam (264), the outer shaft including an outer layer (148) over the inner layer and the outlet pathway connector (200) at the seam.

5. The catheter assembly (100) according to claim 1, wherein: The outer shaft (112) includes a hypotube defining the outer shaft bore (136), the outlet pathway connector (200) being connected to the hypotube at a seam (264), the outer shaft including a polymer sheath formed in position around the hypotube and the outlet pathway connector at the seam.

6. The catheter assembly (100) according to claim 1, wherein: The outlet pathway connector (200) includes a rearwardly extending rear engagement portion (250) of the rigid body portion (210), the rear engagement portion being connected to the outer shaft body (130).

7. The catheter assembly (100) according to claim 1, wherein: The outer shaft (112) includes an inner layer (146) defining the outer shaft hole (136) and an outer layer (148) surrounding the outside of the inner layer, the front joint portion (240) is connected to the inner layer at a seam (264), and the outer layer is seamlessly connected to the inner layer and the joint portion at the seam.

8. The catheter assembly (100) according to claim 1, wherein: The rigid body portion (210) includes an inner surface (226) and an outer surface (228), the inner surface defining the outlet pathway connector aperture (216), the side outlet port (220) extending between the inner surface and the outer surface at an angle transverse to the aperture axis (224) of the outlet pathway connector aperture.

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